- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07440433
Home-Based Physiotherapy in Oncology
Home-Based Physiotherapy for Oncology Patients: Feasibility and Acceptability of a Supervised Exercise Programme
The goal of this clinical trial is to assess the feasibility, acceptability, and safety of a supervised home-based physiotherapy programme for adult oncology patients. The programme combines aerobic cycling exercise, resistance training, and mental preparation strategies, delivered at home with regular professional supervision.
The main questions this study aims to answer are:
Is a 6-month supervised home-based physiotherapy programme feasible in terms of recruitment, adherence, and retention?
Is the programme safe for oncology patients undergoing or having recently completed cancer treatment?
Is the programme acceptable and satisfactory from the patient's perspective?
How do physical function and health-related quality of life change over the course of the programme?
This is a single-arm feasibility study with no comparison group.
Participants will:
Receive a stationary exercise bike delivered and installed at their home
Follow a 6-month individualized physiotherapy programme including:
Three weekly sessions combining moderate-intensity cycling and resistance exercises
Wear a connected activity watch during exercise sessions to monitor heart rate and exercise duration
Receive weekly supervision from oncology-trained physiotherapists through alternating in-person hospital visits and structured phone calls
Complete physical function assessments and questionnaires on quality of life, fatigue, and programme satisfaction at baseline, mid-program, and study completion
The results of this study will inform the design of a future larger controlled trial and contribute to the development of accessible home-based rehabilitation programmes for oncology patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective, single-centre, single-arm feasibility clinical trial conducted at the Geneva University Hospitals (HUG). It evaluates the implementation of a long-duration supervised home-based physiotherapy programme for adult oncology patients.
A total of 21 participants will be enrolled in three sequential cohorts of approximately seven participants each. Each participant will follow a single 6-month intervention period; cohorts are implemented sequentially for logistical and organisational reasons but follow identical study procedures.
The intervention consists of a 6-month home-based physiotherapy programme combining aerobic cycling exercise, resistance training, and mental preparation strategies. At study initiation, a stationary exercise bike is delivered and installed in the participant's home. An individualized exercise prescription is developed by oncology-trained physiotherapists based on baseline functional assessments and clinical status.
Participants are asked to complete three supervised exercise sessions per week. Each session includes approximately 20 minutes of moderate-intensity aerobic cycling followed by 20 minutes of resistance training. Exercise intensity is prescribed and monitored using perceived exertion and heart rate criteria consistent with current oncology exercise guidelines. A connected activity watch is provided to each participant and worn only during exercise sessions to record heart rate and exercise duration.
Supervision is ensured through weekly contact with oncology physiotherapists, alternating between in-person hospital visits and structured telephone calls. In-person visits include functional reassessments, programme adjustments, symptom review, safety monitoring, and mental preparation sessions. Mental preparation integrates motivational interviewing techniques, goal setting, routine development, and basic mindfulness and imagery strategies aimed at supporting adherence and self-management.
The primary focus of the study is feasibility, assessed through recruitment capability, adherence to prescribed exercise sessions, participant retention over the 6-month period, and successful delivery and use of the home-based equipment. Safety is assessed through systematic monitoring and reporting of adverse events related to the intervention.
Secondary outcomes include changes in physical function and patient-reported outcomes. Functional performance is assessed using standardized physical tests at baseline and at the end of the intervention. Patient-reported outcomes, including health-related quality of life, fatigue, and programme acceptability, are collected at baseline, mid-program (3 months), and study completion (6 months).
All analyses are descriptive and aim to provide feasibility indicators and operational insights to inform the design of a future controlled trial and potential integration of supervised home-based physiotherapy into routine oncology care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Floryane Dr Kim
- Phone Number: +41 22 372 98 62
- Email: floryane.kim@hug.ch
Study Locations
-
-
-
Geneva, Switzerland, 1205
- HUG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of solid cancer, undergoing or recently completed treatment.
- Overall survival greater than 12 months, as judged by the treating oncologist
- Clinically stable and deemed fit for moderate exercise by the treating oncologist
- Able to use an exercise bike
- Home environment suitable for delivery and installation of the exercise bike
- Able to understand the study language and follow study instructions
- Able to give a written informed consent
Exclusion Criteria:
- Medical contraindication to moderate exercise (e.g. uncontrolled cardiac or pulmonary disease, recent myocardial infarction, severe anemia or acute infection, unstable bone metastases or high fracture risk)
- Cognitive impairment preventing active participation
- Physical inability to perform the prescribed exercise programme, including cycling and resistance exercises.
- Participation in another intensive rehabilitation program
- Any other condition that, in the opinion of the treating oncologist or investigator, makes participation unsafe or not feasible
- Pregnant or lactating women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Home-based supervised physiotherapy programme
Participants enrolled in this single-arm study receive a 6-month supervised home-based physiotherapy programme combining aerobic cycling, resistance training, and mental preparation, delivered and monitored by oncology-trained physiotherapists.
|
Participants complete a 6-month supervised home-based physiotherapy programme. The intervention includes three weekly exercise sessions consisting of approximately 20 minutes of moderate-intensity aerobic cycling followed by 20 minutes of resistance training. Exercise intensity is prescribed and monitored using perceived exertion and heart rate. A stationary exercise bike is delivered and installed at the participant's home. Participants receive weekly supervision by oncology-trained physiotherapists through alternating in-person hospital visits and structured telephone calls. Mental preparation strategies, including motivational support and goal setting, are integrated during in-person visits to support adherence and self-management. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention rate
Time Frame: 6 months
|
Percentage of participants completing the 6-month intervention and final assessments.
|
6 months
|
|
Adherence to prescribed exercise sessions
Time Frame: 6 months
|
Percentage of planned home-based exercise sessions completed over 6 months.
|
6 months
|
|
Equipment installation and usability
Time Frame: 6 months
|
Percentage of participants with successful delivery, installation, and safe use of the home-based exercise equipment.
|
6 months
|
|
Safety of the intervention
Time Frame: 6 months
|
Number and type of adverse events and serious adverse events related to the programme.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-minute walk test
Time Frame: Baseline and 6 months
|
Distance walked during the 6-minute walk test (meters).
|
Baseline and 6 months
|
|
Peak oxygen uptake (VO₂peak)
Time Frame: Baseline and 6 months
|
Peak oxygen uptake measured during cardiopulmonary exercise testing (CPET), expressed in mL/kg/min.
|
Baseline and 6 months
|
|
5 Times Sit-to-Stand Test (5xSST)
Time Frame: Baseline and 6 months
|
Time to complete five sit-to-stand repetitions (seconds).
|
Baseline and 6 months
|
|
Handgrip strength
Time Frame: Baseline and 6 months
|
Maximal grip strength measured with a dynamometer (kilograms).
|
Baseline and 6 months
|
|
Health-related quality of life (EORTC QLQ-C30 global health status score)
Time Frame: Baseline, 3 months, and 6 months
|
Quality of life assessed using the EORTC QLQ-C30 questionnaire.
Scores range from 0 to 100.
Higher scores on the global health status scale indicate better quality of life.
|
Baseline, 3 months, and 6 months
|
|
Participant satisfaction score
Time Frame: 3 months and 6 months
|
Participant satisfaction assessed using a study-specific questionnaire (score range 0-10, higher scores indicate greater satisfaction).
|
3 months and 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRADA-HUG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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